BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NKII DURASUL U/CONG TIB INS SZ 00/0, LT, 16MM

    MDR report key: 521833 · Received April 22, 2004

    Report

    Report Number
    2935620-2004-00041
    Event Type
    Injury
    Date Received
    April 22, 2004
    Date of Event
    February 3, 2004
    Report Date
    April 22, 2004
    Manufacturer
    CENTERPULSE ORTHOPEDICS, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: PT WAS REVISED IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NKII DURASUL U/CONG TIB INS SZ 00/0, LT, 16MM KNEE PROSTHESIS HSH CENTERPULSE ORTHOPEDICS, INC. NA 1455061

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization 6215-00-090 REV TIB STM SZ90MM NKII| (LOT#151958) (2004).| 6307-00-008 NP FEM LT. SZO NKII (LOT#1506639-A)(04